Door‐to‐Puncture: A Practical Metric for Capturing and Enhancing System Processes Associated With Endovascular Stroke Care, Preliminary Results From the Rapid Reperfusion Registry

Background: In 2011, the Brain Attack Coalition proposed door‐to‐treatment times of 2 hours as a benchmark for patients undergoing intra‐arterial therapy (IAT). We designed the Rapid Reperfusion Registry to capture the percentage of stroke patients who meet the target and its impact on outcomes. Methods and Results: This is a retrospective analysis of anterior circulation patients treated with IAT within 9 hours of symptom onset. Data was collected from December 31, 2011 to December 31, 2012 at 2 centers and from July 1, 2012 to December 31, 2012 at 7 centers. Short “Door‐to‐Puncture” (D2P) time was hypothesized to be associated with good patient outcomes. A total of 478 patients with a mean age of 68±14 years and median National Institutes of Health Stroke Scale (NIHSS) of 18 (IQR 14 to 21) were analyzed. The median times for IAT delivery were 234 minutes (IQR 163 to 304) for “last known normal‐to‐groin puncture” time (LKN‐to‐GP) and 112 minutes (IQR 68 to 176) for D2P time. The overall good outcome rate was 39.7% for the entire cohort. In a multivariable model adjusting for age, NIHSS, hypertension, diabetes, reperfusion status, and symptomatic hemorrhage, both short LKN‐to‐GP (OR 0.996; 95% CI [0.993 to 0.998]; P<0.001) and short D2P times (OR 0.993, 95% CI [0.990 to 0.996]; P<0.001) were associated with good outcomes. Only 52% of all patients in the registry achieved the targeted D2P time of 2 hours. Conclusions: The time interval of D2P presents a clinically relevant time frame by which system processes can be targeted to streamline the delivery of IAT care nationally. At present, there is much opportunity to enhance outcomes through reducing D2P

Primary results from the CLEAR study of a novel stent retriever with drop zone technology

Background: Challenges to revascularization of large vessel occlusions (LVOs) persist. Current stent retrievers have limited effectiveness for removing organized thrombi. The NeVa device is a novel stent retriever designed to capture organized thrombi within the scaffold during retrieval. Objective: To evaluate the safety and effectiveness of revascularization of acute LVOs with the NeVa device. Methods: Prospective, international, multicenter, single-arm, Investigational Device Exemption study to evaluate the performance of the NeVa device in recanalizing LVOs including internal carotid artery, M1/M2 middle cerebral artery, and vertebrobasilar arteries, within 8 hours of onset. Primary endpoint was rate of expanded Treatment in Cerebral Ischemia (eTICI) score 2b-3 within 3 NeVa passes, tested for non-inferiority against a performance goal of 72% with a -10% margin. Additional endpoints included first pass success and 90-day modified Rankin Scale (mRS) score 0-2. Primary composite safety endpoint was 90-day mortality and/or 24-hour symptomatic intracranial hemorrhage (sICH). Results: From April 2021 to April 2022, 139 subjects were enrolled at 25 centers. Median National Institutes of Health Stroke Scale (NIHSS) score was 16 (IQR 12-20). In the primary analysis population (n=107), eTICI 2b-3 within 3 NeVa passes occurred in 90.7% (97/107; non-inferiority P<0.0001; post hoc superiority P<0.0001). First pass eTICI 2b-3 was observed in 73.8% (79/107), with first pass eTICI 2b67-3 in 69.2% (74/107) and eTICI 2c-3 in 48.6% (52/107). Median number of passes was 1 (IQR 1-2). Final eTICI 2b-3 rate was 99.1% (106/107); final eTICI 2b67-3 rate was 91.6% (98/107); final eTICI 2c-3 rate was 72.9% (78/107). Good outcome (90-day mRS score 0-2) was seen in 65.1% (69/106). Mortality was 9.4% (13/138) with sICH in 5.0% (7/139). Conclusions: The NeVa device is highly effective and safe for revascularization of LVO strokes and demonstrates superior first pass success compared with a predicate performance goal. Trial registration number: NCT04514562

Thrombectomy Outcomes With General vs Nongeneral Anesthesia: A Pooled Patient-Level Analysis From the EXTEND-IA Trials and SELECT Study

BACKGROUND AND OBJECTIVES: The effect of anesthesia choice on endovascular thrombectomy (EVT) outcomes is unclear. Collateral status on perfusion imaging may help identify the optimal anesthesia choice. METHODS: In a pooled patient-level analysis of EXTEND-IA, EXTEND-IA TNK, EXTEND-IA TNK part II, and SELECT, EVT functional outcomes (modified Rankin Scale score distribution) were compared between general anesthesia (GA) vs non-GA in a propensity-matched sample. Furthermore, we evaluated the association of collateral flow on perfusion imaging, assessed by hypoperfusion intensity ratio (HIR) - Tmax \u3e 10 seconds/Tmax \u3e 6 seconds (good collaterals - HIR \u3c 0.4, poor collaterals - HIR ≥ 0.4) on the association between anesthesia type and EVT outcomes. RESULTS: Of 725 treated with EVT, 299 (41%) received GA and 426 (59%) non-GA. The baseline characteristics differed in presentation National Institutes of Health Stroke Scale score (median [interquartile range] GA: 18 [13-22], non-GA: 16 [11-20], DISCUSSION: GA was associated with worse functional outcomes after EVT, particularly in patients with poor collaterals in a propensity score-matched analysis from a pooled patient-level cohort from 3 randomized trials and 1 prospective cohort study. The confounding by indication may persist despite the doubly robust nature of the analysis. These findings have implications for randomized trials of GA vs non-GA and may be of utility for clinicians when making anesthesia type choice. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that use of GA is associated with worse functional outcome in patients undergoing EVT. TRIAL REGISTRATION INFORMATION: EXTEND-IA: ClinicalTrials.gov (NCT01492725); EXTEND-IA TNK: ClinicalTrials.gov (NCT02388061); EXTEND-IA TNK part II: ClinicalTrials.gov (NCT03340493); and SELECT: ClinicalTrials.gov (NCT02446587)

Thrombectomy Outcomes With General vs Nongeneral Anesthesia: A Pooled Patient-Level Analysis From the EXTEND-IA Trials and SELECT Study

Background and Objectives The effect of anesthesia choice on endovascular thrombectomy (EVT) outcomes is unclear. Collateral status on perfusion imaging may help identify the optimal anesthesia choice. Methods In a pooled patient-level analysis of EXTEND-IA, EXTEND-IA TNK, EXTEND-IA TNK part II, and SELECT, EVT functional outcomes (modified Rankin Scale score distribution) were compared between general anesthesia (GA) vs non-GA in a propensity-matched sample. Furthermore, we evaluated the association of collateral flow on perfusion imaging, assessed by hypoperfusion intensity ratio (HIR) – Tmax \u3e 10 seconds/Tmax \u3e 6 seconds (good collaterals – HIR \u3c 0.4, poor collaterals – HIR ≥ 0.4) on the association between anesthesia type and EVT outcomes. Results Of 725 treated with EVT, 299 (41%) received GA and 426 (59%) non-GA. The baseline characteristics differed in presentation National Institutes of Health Stroke Scale score (median [interquartile range] GA: 18 [13–22], non-GA: 16 [11–20], p \u3c 0.001) and ischemic core volume (GA: 15.0 mL [3.2–38.0] vs non-GA: 9.0 mL [0.0–31.0], p \u3c 0.001). In addition, GA was associated with longer last known well to arterial access (203 minutes [157–267] vs 186 minutes [138–252], p = 0.002), but similar procedural time (35.5 minutes [23–59] vs 34 minutes [22–54], p = 0.51). Of 182 matched pairs using propensity scores, baseline characteristics were similar. In the propensity score–matched pairs, GA was independently associated with worse functional outcomes (adjusted common odds ratio [adj. cOR]: 0.64, 95% CI: 0.44–0.93, p = 0.021) and higher neurologic worsening (GA: 14.9% vs non-GA: 8.9%, aOR: 2.10, 95% CI: 1.02–4.33, p = 0.045). Patients with poor collaterals had worse functional outcomes with GA (adj. cOR: 0.47, 95% CI: 0.29–0.76, p = 0.002), whereas no difference was observed in those with good collaterals (adj. cOR: 0.93, 95% CI: 0.50–1.74, p = 0.82), pinteraction: 0.07. No difference was observed in infarct growth overall and in patients with good collaterals, whereas patients with poor collaterals demonstrated larger infarct growth with GA with a significant interaction between collaterals and anesthesia type on infarct growth rate (pinteraction: 0.020). Discussion GA was associated with worse functional outcomes after EVT, particularly in patients with poor collaterals in a propensity score–matched analysis from a pooled patient-level cohort from 3 randomized trials and 1 prospective cohort study. The confounding by indication may persist despite the doubly robust nature of the analysis. These findings have implications for randomized trials of GA vs non-GA and may be of utility for clinicians when making anesthesia type choice. Classification of Evidence This study provides Class III evidence that use of GA is associated with worse functional outcome in patients undergoing EVT. Trial Registration Information EXTEND-IA: ClinicalTrials.gov (NCT01492725); EXTEND-IA TNK: ClinicalTrials.gov (NCT02388061); EXTEND-IA TNK part II: ClinicalTrials.gov (NCT03340493); and SELECT: ClinicalTrials.gov (NCT02446587)

Abstract Number ‐ 189: Comparative Device Analysis for First Pass Stent Retriever Mechanical Thrombectomy

Introduction Limited data is available regarding comparative outcomes amongst FDA‐approved devices for mechanical thrombectomy (MT). The objective of this study is to assess procedural efficacy, clinical outcomes, and safety of currently available stent retriever devices when used during first pass thrombectomy for acute ischemic stroke. Methods A retrospective analysis was performed on all patients who underwent MT for large vessel occlusion (LVO) at a single comprehensive stroke center between January 2016 and January 2022. All patients who underwent MT with a stent retriever (Solitaire, Embotrap, Trevo) during first pass were included in the analysis. Primary efficacy and safety outcomes included time to recanalization, attainment of first‐pass effect (FPE), recanalization TICI score, 90‐day modified Rankin scale (mRS), and incidence of hemorrhagic transformation. One‐way ANOVA was used to compare median time to recanalization amongst cohorts. Chi‐squared test was used to compare frequencies of outcome measures amongst cohorts. Results During the study period, 234 patients underwent MT for LVO with use of stent retriever device during the first pass. In these cases, the type of stent retriever utilized was Solitaire (n = 163), Embotrap (n = 45), or Trevo (n = 26). There were no significant differences between cohorts in terms of age, gender, ethnicity, initial NIH stroke scale, or level of occlusion, or comorbidities. No significant differences were observed between cohorts for any primary outcome measures. The median time to recanalization was 53 min [Solitaire], 49 min [Embotrap], 63 min [Trevo] (p = 0.17). First‐pass effect was attained in 28.6% [Solitaire], 38.4% [Embotrap], 26.9% [Trevo] (p = 0.41). TICI 2b or greater recanalization was attained in 80.3% [Solitaire], 88.9% [Embotrap], 84.6% [Trevo] (p = 0.38). 90‐day mRS of 0–2 was observed in 36.6% [Solitaire], 38.9% [Embotrap], 34.8% [Trevo] (p = 0.95). Hemorrhagic transformation was observed in 45.9% [Solitaire], 36.8% [Embotrap], 34.6% [Trevo] (p = 0.40). Conclusions The type of stent retriever chosen for first pass thrombectomy did not predict procedural efficacy, clinical outcomes, or safety in our single center analysis

Abstract Number ‐ 154: Outcomes of Rescue Intracranial Stenting vs Failed Recanalization during Mechanical Thrombectomy

Introduction Rescue stenting may be considered during mechanical thrombectomy (MT) if a newly recanalized intracranial vessel keeps re‐occluding, or recanalization is not achieved with conventional thrombectomy methods. There are multiple published case series with mixed results on safety and efficacy of this approach, and there are no available randomized trials. We aimed to compare the outcomes of rescue intracranial stenting with unsuccessful/poor reperfusion after MT. Methods Retrospective review of ischemic stroke patients who underwent MT from 2016–2021. Emergent intracranial stent patients were selected and compared with those who had poor/unsuccessful post‐procedural reperfusion (TICI 0–2a). Initial ASPECT score, NIHSS, number of passes, and MT method (aspiration vs stentriever) were recorded. Complications (intracranial hemorrhage, vessel perforation, groin or retroperitoneal hematoma, or distal embolization), final infarct size, 90‐day mRS, and mortality were analyzed. Results Sixteen patients underwent emergent intracranial stenting. Of the 89patients with failed MT, 34 had TICI 2a, 11 had TICI 1, and 44 had TICI 0 reperfusion. All 16 stenting patients achieved TICI 2B‐3 grade recanalization. Pre‐procedure ASPECT score was similar between both groups. Six patients had either intracranial vertebral or basilar artery stenting, and 10 had either intracranial ICA or MCA stenting. Patients with posterior compared to anterior circulation involvement were more likely to receive stenting (50% vs 11%, p = 0.003). There were no differences in the stenting versus non‐stenting group in 24‐hour post intervention NIHSS, post‐procedural complications, intracranial hemorrhage, infarct size, and mortality (75% vs 67%). The stenting group had better functional independence (mRS 0–2) at 90 days (33% vs 11%, p = 0.04). There were no outcome differences in anterior compared to posterior circulation stenting. Conclusions Rescue stenting was more often seen with posterior circulation strokes. In patients with failed or unsuccessful reperfusion after conventional MT, emergent stenting achieved better 90‐day functional independence without increasing rates of complications, intracranial hemorrhage, or mortality

Abstract Number ‐ 161: Comparing Stroke Thrombectomy Outcomes In Younger V/S Older Population

Introduction Large vessel occlusion (LVO) is estimated to account for up to 39% of all ischemic strokes with 62% of them resulting in post‐ischemic stroke dependency and 96% of all post‐ischemic stroke mortality. Advanced imaging modalities and efficient stroke systems of care have resulted in faster reperfusion times. There is however limited data on the outcomes of thrombectomy as a function of age. We present a retrospective analysis on thrombectomy in younger (age 18–49 years) versus older (age >50 years) patients. Methods Retrospective single center study with population being identified using our procedural database and “SlicerDicer” tool on EPIC from 2017–2021. Patients who underwent mechanical thrombectomy were divided into 2 groups based on age. Younger group consists of patients between the ages 18–49 while older group is 50 and over. Primary outcome of the study was to identify good clinical outcome as defined by mRS of 0–2 in both groups. Secondary outcomes included rate of favorable reperfusion defined by TICI 2b‐3, symptomatic ICH and mortality rate. Results > We have identified 48 patients between the age of 18–49 and 436 over the age of 50. > We found that median groin puncture to repercussion time was lower in younger population (32 v/s 69 mins; p = 0.0044) > The median groin puncture to first pass time was lower in younger population (22 v/s 43; p = 0.056), but it failed to show statistical significance. > Younger compared to older patients had better clinical outcomes (mRS 0–2) at 77.1% v/s 32.3% (p The older group required more passes to achieve recanalization (4 or more passes: 4.3% v/s 16.2%; p = 0.035) > Mortality rate was significantly less in the younger population (8.3% v/s 22.1%; p = 0.026) Conclusions Younger patients had better clinical outcomes than their older counterparts after mechanical thrombectomy in our analysis. Other than younger age, higher rates of favorable repercussion, earlier recanalization, and less passes to recanalization were seen in association with better observed outcomes

Comparison of Acute Ischemic Stroke Care and Outcomes Between Comprehensive Stroke Centers and Primary Stroke Centers in the United States

BackgroundTo improve stroke care, the Brain Attack Coalition recommended establishing primary stroke center (PSC) and comprehensive stroke center (CSC) certification. This study aimed to compare ischemic stroke care and in-hospital outcomes between CSCs and PSCs.Methods and resultsWe analyzed patients with acute ischemic stroke who were hospitalized at stroke centers participating in Get With The Guidelines-Stroke from 2013 to 2015. Multivariable logistic regression models were generated to examine the association between stroke center certification (CSC versus PSC) and performances and outcomes. This study included 722 941 patients who were admitted to 134 CSCs and 1047 PSCs. Both CSCs and PSCs had good conformity to 7 performance measures and the summary defect-free care measure. Among emergency department admissions, CSCs had higher intravenous tPA (tissue-type plasminogen activator) and endovascular thrombectomy rates than PSCs (14.3% versus 10.3%, 4.1% versus 1.0%, respectively). Door to intravenous tPA time was shorter at CSCs (median, 52 versus 61 minutes; adjusted risk ratio, 0.92; 95% confidence interval, 0.89-0.95). More patients at CSCs had door to intravenous tPA time ≤60 minutes (79.7% versus 65.1%; adjusted odds ratio, 1.48; 95% confidence interval, 1.25-1.75). For transferred patients, CSCs and PSCs had comparable overall performance in defect-free care, except higher endovascular thrombectomy therapy rates. The overall in-hospital mortality was higher at CSCs in both emergency department admissions (4.6% versus 3.8%; adjusted odds ratio, 1.14; 95% confidence interval, 1.01-1.29) and transferred patients (7.7% versus 6.8%; adjusted odds ratio, 1.17; 95% confidence interval, 1.05-1.32). In-hospital outcomes were comparable between CSCs and PSCs in patients who received intravenous tPA or endovascular thrombectomy.ConclusionsCSCs and PSCs achieved similar overall care quality for patients with acute ischemic stroke. CSCs exceeded PSCs in timely acute reperfusion therapy for emergency department admissions, whereas PSCs had lower risk-adjusted in-hospital mortality. This information may be important for acute stroke triage and targeted quality improvement

Coronavirus Disease 2019 and Stroke: Clinical Manifestations and Pathophysiological Insights

Coronavirus disease 2019 (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is a global health threat. Some COVID-19 patients have exhibited widespread neurological manifestations including stroke. Acute ischemic stroke, intracerebral hemorrhage, and cerebral venous sinus thrombosis have been reported in patients with COVID-19. COVID-19-associated coagulopathy is increasingly recognized as a result of acute infection and is likely caused by inflammation, including inflammatory cytokine storm. Recent studies suggest that axonal transport of SARS-CoV-2 to the brain can occur via the cribriform plate adjacent to the olfactory bulb that may lead to symptomatic anosmia. The internalization of SARS-CoV-2 is mediated by the binding of the spike glycoprotein of the virus to the angiotensin-converting enzyme 2 (ACE2) on cellular membranes. ACE2 is expressed in several tissues including lung alveolar cells, gastrointestinal tissue, and brain. The aim of this review is to provide insights into the clinical manifestations and pathophysiological mechanisms of stroke in COVID-19 patients. SARS-CoV-2 can down-regulate ACE2 and, in turn, overactivate the classical renin-angiotensin system (RAS) axis and decrease the activation of the alternative RAS pathway in the brain. The consequent imbalance in vasodilation, neuroinflammation, oxidative stress, and thrombotic response may contribute to the pathophysiology of stroke during SARS-CoV-2 infection